Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
CA 02836601 2013-12-13
IRRIGATED CATHETER TIP WITH TEMPERATURE SENSOR ARRAY
FIELD OF THE INVENTION
The present invention relates generally to invasive
medical devices, and particularly to probes used in
ablating tissue within the body.
BACKGROUND
Minimally-invasive intracardiac ablation is the
treatment of choice for various types of arrhythmias. To
perform such treatment, the physician typically inserts a
catheter through the vascular system into the heart,
brings the distal end of the catheter into contact with
myocardial tissue in areas of abnormal electrical
activity, and then energizes one or more electrodes at or
near the distal end in order to create tissue necrosis.
It has been found that cooling the area of the
ablation site reduces tissue charring and thrombus
formation. For this
purpose, for example, Biosense
Webster Inc. (Diamond Bar, Calif.) offers the ThermoCool0
irrigated-tip catheter for use with its CARTOO integrated
mapping and ablation system. The metal
catheter tip,
which is energized with radio-frequency (RE) electrical
current to ablate the Lis5ue, has a number of peripheral
holes, distributed circumferentially around the tip, for
irrigation of the treatment site. A pump coupled to the
catheter delivers saline solution to the catheter tip,
and the solution flows out through the holes during the
procedure in order to cool the catheter tip and the
tissue.
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U.S. Patent Application Publication 2010/0030209
describes a catheter with a perforated tip, which
includes an insertion tube, having a distal end for
insertion into a body of a subject. A distal
tip is
fixed to the distal end of the insertion tube and is
coupled to apply energy to tissue inside the body. The
distal tip has an outer surface with a plurality of
perforations through the outer surface, which are
distributed circumferentially and longitudinally over the
distal tip. A lumen
passes through the insertion tube
and is coupled to deliver a fluid to the tissue via the
perforations.
Some ablation catheters include sensors for
monitoring temperature during the ablation procedure.
For example, U.S. Patent 5,957,961 describes a catheter
having a distal segment carrying at least one electrode
extending along the segment and having a number of
temperature sensors arranged along the distal segment
adjacent the electrode, each providing an output
indicative of temperature. The catheter is coupled to a
power source, which provides RF energy to the electrode.
Temperature processing circuitry is coupled to the
temperature sensors and the power source, and controls
power output from the power source as a function of the
outputs of the temperature sensors.
As another example, U.S. Patent 6,312,425 describes
an RF ablation catheter tip electrode with multiple
thermal sensors. A tip thermal sensor is located at or
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near the apex of the distal-end region, and one or more
side thermal sensors are located near the surface of the
proximal-end region. The
electrode is preferably an
assembly formed from a hollow dome-shaped shell with a
core disposed within the shell. The side thermal sensor
wires are electrically connected inside the shell and the
core has a longitudinal channel for the side thermal
sensor wires welded to the shell. The shell
also
preferably has a pocket in the apex of the shell, and the
end thermal sensor wires pass through the core to the
apex of the shell.
SUMMARY
Embodiments of the present invention that are
described hereinbelow provide ablation probes with
enhanced temperature measurement capabilities.
There is therefore provided, in accordance with an
embodiment of the present invention, a medical probe,
which includes an insertion tube having a distal end
configured for insertion into a body of a patient and
containing a lumen for conveying an irrigation fluid and
an electrical conductor for conveying electrical energy.
A conductive cap is attached to the distal end of the
insertion tube and coupled electrically to the electrical
conductor. The
conductive cap has an outer surface
perforated by multiple apertures and defines an inner
cavity in fluid communication with the lumen of the
insertion tube so as to permit the irrigation fluid from
the lumen to flow out of the cap through the apertures.
A plurality of temperature sensors are mounted within the
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conductive cap in thermal communication with the outer
surface and are thermally insulated from the irrigation
fluid in the inner cavity.
In one embodiment, the cap includes multiple ribs
internal to the outer surface, and the temperature
sensors are mounted inside the ribs.
In another embodiment, the probe includes an inner
wall inside and parallel to the cap, wherein the inner
cavity is contained between the inner wall and the cap,
and the temperature sensors are mounted between the inner
wall and the cap. The probe
may include multiple
spacers, which are located within the inner cavity and
connect the cap to the inner wall, wherein the
temperature sensors are mounted in the spacers.
In still another embodiment, the cap includes a side
wall having multiple longitudinal bores therein, and the
temperature sensors are fitted into and mounted in the
bores.
Typically, the temperature sensors are arrayed
around the cap at different circumferential and axial
positions. The
temperature sensors may be arranged in
pairs that are axially spaced apart at different
circumferential locations.
In a disclosed embodiment, the insertion tube is
configured as a catheter for insertion into a heart of
the patient, and the conductive cap is configured to
contact and apply the electrical energy to myocardial
tissue in the heart so as to ablate the myocardial
tissue.
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There is also provided, in accordance with an
embodiment of the present invention, medical apparatus,
which include a probe as described above. A pump is
coupled to the lumen at the proximal end of the insertion
tube so as to supply the irrigation fluid to the probe.
A power generator is coupled to the electrical conductor
at the proximal end of the insertion tube so as to
provide the electrical energy to the conductive cap.
Monitoring circuitry is connected to receive temperature
signals from the temperature sensors so as to monitor a
temperature of the cap.
In a disclosed embodiment, the monitoring circuitry
is configured to select a highest temperature reading
from among the plurality of the temperature sensors and
to control at least one of the pump and the power
generator responsively to the highest temperature
reading.
There is additionally provided, in accordance with
an embodiment of the present invention, a method for
medical treatment, which includes inserting a probe, as
described above, into a body of a patient. The
conductive cap is brought into contact with tissue within
the body. Electrical
energy is applied via the
electrical conductor to the cap so ablate the tissue,
while supplying the irrigation fluid via the lumen in
order to irrigate the tissue. A
temperature of the
conductive cap is monitored using the temperature sensors
while ablating the tissue.
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Inserting the probe may include advancing the probe
into a heart of the patient, so as to apply the
electrical energy to myocardial tissue.
There is further provided, in accordance with an
embodiment of the present invention, a method for
producing a medical probe, which includes providing an
insertion tube having a distal end configured for
insertion into a body of a patient and containing a lumen
for conveying an irrigation fluid and an electrical
conductor for conveying electrical energy. A conductive
cap is formed, having an outer surface perforated by
multiple apertures and defining an inner cavity. The
conductive cap is attached to the distal end of the
insertion tube with the inner cavity in fluid
communication with the lumen of the insertion tube so as
to permit the irrigation fluid from the lumen to flow out
of the cap through the apertures. The conductive cap is
coupled electrically to the electrical conductor. A
plurality of temperature sensors are mounted within the
conductive cap in thermal communication with the outer
surface, while thermally insulating the temperature
sensors from the irrigation fluid in the inner cavity.
In one embodiment of the invention, there is
provided a medical probe comprising an insertion tube, a
conductive cap, a plurality of temperature sensors, a
thin inner wall and multiple spacers. The insertion tube
has a distal end configured for insertion into a body of
a patient. The
insertion tube contains a lumen for
conveying an irrigation fluid and an electrical conductor
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for conveying electrical energy. The
conductive cap is
attached to the distal end of the insertion tube and
coupled electrically to the electrical conductor. The
conductive cap has an outer surface perforated by
multiple apertures. The conductive cap defines an inner
cavity in fluid communication with the lumen of the
insertion tube so as to permit the irrigation fluid from
the lumen to flow out of the cap through the apertures.
The plurality of temperature sensors are mounted within
the conductive cap in thermal communication with the
outer surface. The plurality of temperature sensors are
thermally insulated from the irrigation fluid in the
inner cavity. The thin inner wall is inside and parallel
to the cap. The inner cavity is contained between the
thin inner wall and the cap. The temperature sensors are
mounted between the thin inner wall and the cap. The
multiple spacers are located within the inner cavity and
connect the cap to the thin inner wall. The temperature
sensors are mounted in the spacers.
In another embodiment of the invention, there is
provided a medical probe comprising an insertion tube, a
conductive cap and a plurality of temperature sensors.
The insertion tube has a distal end configured for
insertion into a body of a patient. The insertion tube
contains a lumen for conveying an irrigation fluid and an
electrical conductor for conveying electrical energy.
The conductive cap is attached to the distal end of the
insertion tube and is coupled electrically to the
electrical conductor. The conductive cap has an outer
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surface perforated by multiple apertures. The conductive
cap defines an inner cavity in fluid communication with
the lumen of the insertion tube so as to permit the
irrigation fluid from the lumen to flow out of the cap
5 through the apertures. The plurality of temperature
sensors are mounted within the conductive cap in thermal
communication with the outer surface and are thermally
insulated from the irrigation fluid in the inner cavity.
The cap comprises multiple ribs internal to the outer
surface. The temperature sensors are mounted inside the
ribs.
In another embodiment of the invention, there is provided
a method for producing a medical probe. The
method
includes providing an insertion tube having a distal end
configured for insertion into a body of a patient and
containing a lumen for conveying an irrigation fluid and
an electrical conductor for conveying electrical energy.
The method includes forming a conductive cap having an
outer surface perforated by multiple apertures and
defining an inner cavity. The method includes attaching
the conductive cap to the distal end of the insertion
tube with the inner cavity in fluid communication with
the lumen of the insertion tube so as to permit the
irrigation fluid from the lumen to flow out of the cap
through the apertures. The method includes coupling the
conductive cap electrically to the electrical conductor.
The method includes mounting a plurality of temperature
sensors within the conductive cap in thermal
communication with the outer surface
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while thermally insulating the temperature sensors from
the irrigation fluid in the inner cavity. The
method
includes mounting a thin inner wall inside and parallel
to the cap. The
inner cavity is contained between the
thin inner wall and the cap. The temperature sensors are
mounted between the thin inner wall and the cap. The
method includes providing multiple spacers, which are
located within the inner cavity and connect the cap to
the thin inner wall. The temperature sensors are mounted
in the spacers.
In another embodiment of the invention, there is
provided a method for producing a medical probe. The
method includes providing an insertion tube having a
distal end configured for insertion into a body of a
patient and containing a lumen for conveying an
irrigation fluid and an electrical conductor for
conveying electrical energy. The method includes forming
a conductive cap having an outer surface perforated by
multiple apertures and defining an inner cavity. The
method includes attaching the conductive cap to the
distal end of the insertion tube with the inner cavity in
fluid communication with the lumen of the insertion tube
so as to permit the irrigation fluid from the lumen to
flow out of the cap through the apertures. The
method
includes coupling the conductive cap electrically to the
electrical conductor. The
method includes mounting a
plurality of temperature sensors within the conductive
cap in thermal communication with the outer surface while
thermally insulating the temperature sensors from the
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irrigation fluid in the inner cavity. The
method
includes mounting multiple ribs internal to the outer
surface. The temperature sensors are mounted inside the
ribs.
The present invention will be more fully understood
from the following detailed description of the
embodiments thereof, taken together with the drawings in
which:
BRIEF DESCRIPTION OF THE DRAWING
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Fig. 1 is a schematic, pictorial illustration of a
system for intracardiao ablation, in accordance with an
embodiment of the present invention;
Fig. 2A is a schematic, sectional view of a catheter
tip, in accordance with an embodiment of the present
invention;
Fig. 2B is a schematic, cross-sectional view of the
catheter tip of Fig. 2A;
Fig. 3 is a schematic, sectional view of a catheter
tip, in accordance with another embodiment of the present
invention;
Fig. 4A is a schematic, pictorial illustration of a
catheter cap, in accordance with yet another embodiment
of the present invention;
Fig. 4B is a schematic end view of the catheter cap
of Fig. 4A; and
Fig. 40 is a schematic, sectional view of the
catheter cap of Figs. 4A and 4B.
DETAILED DESCRIPTION OF EMBODIMENTS
Intracardiac ablation procedures are characterized
by rapid temperature changes and non-uniform temperature
distribution in the tissue and its vicinity. Therefore,
the temperature measured by a sensor at the tip of an
ablation catheter may not accurately reflect the actual,
current temperature in the tissue. Furthermore,
when a
temperature sensor in a catheter is washed by irrigation
fluid, the temperature reading will reflect the fluid
temperature, which is generally far cooler than the
tissue temperature outside the catheter.
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Embodiments of the present invention that are
described hereinbelow provide irrigated ablation
electrodes with embedded temperature sensors that provide
accurate tissue temperature assessment. Such electrodes
typically comprise a conductive cap, which is attached to
the distal tip of the insertion tube of an invasive
probe, such as a cardiac catheter. A cooling fluid flows
out through an array of perforations in the electrode to
irrigate the tissue under treatment.
The temperature sensors are mounted at different
locations in proximity to the outer surface of the
electrode. The
electrode is constructed so that the
sensors are in proximity to and thermal communication
with the outer surface, and are thermally insulated from,
rather than immersed in, the cooling fluid within the
probe. The sensors
thus provide multiple temperature
readings that are substantially independent of the
cooling fluid temperature, at different locations on the
tip electrode.
Typically, the sensor that gives the highest
temperature reading is the one that is in contact with
the tissue being ablated, and the temperature measured by
this sensor varies linearly with the actual tissue
temperature. (Flow of the
cooling fluid through the
perforations in the electrode is generally lowest in
areas that are in firm contact with the tissue, and the
sensors in these areas typically give the highest
temperature readings.) The reading
from this hottest
sensor may thus be used in particular to monitor the
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tissue temperature and control the applied power and
duration of the ablation procedure in order to obtain the
desired therapeutic result without excessive tissue
damage.
Alternatively or additionally, the temperature
readings of the multiple sensors can be combined and
interpolated to give a map of temperature over the area
of the catheter tip.
Although the disclosed embodiments relate
specifically to intracardiac catheters and ablation
procedures, the principles of the present invention may
similarly be applied, mutatis mutandis, to probes of
other types, for use in substantially any sort of
invasive thermal treatment.
Fig. 1 is a schematic pictorial illustration of a
system 20 for cardiac ablation treatment, in accordance
with an embodiment of the present invention. An operator
28 (such as an interventional cardiologist) inserts a
catheter 22 via the vascular system of a patient 26 into
a chamber of the patient's heart 24. For example,
to
treat atrial fibrillation, the operator may advance the
catheter into the left atrium and bring a distal end 30
of the catheter into contact with myocardial tissue that
is to be ablated.
Catheter 22 is connected at its proximal end to a
console 32, which is controlled by operator 28 to apply
and monitor the desired treatment. Console 32 comprises
an RE energy generator 34, which supplies electrical
power via catheter 22 to distal end 30 in order to ablate
the target tissue. Monitoring circuitry 36 tracks the
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temperature of the tissue at distal end 30 by processing
the outputs of temperature sensors in the distal end, as
described below. An
irrigation pump 38 supplies a
cooling fluid, such as saline solution, through catheter
22 to irrigate distal end 30. On the basis
of
information provided by monitoring circuitry 36, console
32 may control the power applied by RE energy generator
34 and/or the flow of fluid provided by pump 38, either
automatically or in response to inputs by operator 28.
System 20 may be based on the above-mentioned CARTO
system, for example, which provides extensive facilities
to support navigation and control of catheter 22. These
system facilities, however, including details of the
monitoring and control functions of monitoring circuitry
36 and console 32 generally, are beyond the scope of the
present patent application.
Figs. 2A and 2B schematically illustrate distal end
30 of catheter 22, in accordance with an embodiment of
the present invention. Fig. 2A is a sectional view along
the length of the catheter, while Fig. 2B is a cross-
sectional view along the cut I1B-IIB that is marked in
Fig. 2A. An insertion
tube 42 extends along the length
of the catheter and is connected at its distal end to a
conductive cap 44. Typically,
insertion tube 42
comprises a flexible, biocompatible polymer, while cap 44
comprises a biocompatible metal suitable to serve as an
ablation electrode, such as gold or platinum, for
example. Cap 44 is perforated by an array of irrigation
apertures 46, which open from the outer surface of the
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cap into an inner cavity 58 within the cap. For typical
intracardiac ablation applications, the diameter of cap
44 may be about 2.5 mm, with a wall thickness of about
0.2 mm and apertures 46 of diameter 0.1-0.2 mm. The
above dimensions and materials are described by way of
example, however, and other suitable materials, with
features of larger or smaller dimensions, may similarly
be used.
Cavity 58 is in fluid communication with a lumen 54,
which runs through the length of insertion tube 42.
Lumen 54 is coupled at its proximal end to irrigation
pump 38, and thus conveys irrigation fluid to cavity 58,
from which the fluid flows out through apertures 46. An
electrical conductor 56 conveys electrical energy from RE
generator 34, through insertion tube 42, to cap 44, and
thus energizes the cap to ablate myocardial tissue with
which the cap is in contact. During ablation, the fluid
flowing out through apertures 46 irrigates the tissue
under treatment.
Temperature sensors 48 are mounted within conductive
cap 44 at locations that are arrayed around the distal
tip of the catheter, both axially and circumferentially.
In this example, cap 44 contains six sensors, with one
group in a distal location, close to the tip, and the
other group in a slightly more proximal location. This
distribution is shown only by way of example, however,
and greater or smaller numbers of sensors may be mounted
in any suitable locations within the cap. Sensors 48 may
comprise thermocouples, thermistors, or any other
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suitable type of miniature temperature sensor. These
sensors are connected by leads 52 running through the
length of insertion tube 42 to provide temperature
signals to monitoring circuitry 36.
Temperature sensors 48 are mounted within ribs 50
inside cap 44. The ribs are typically an integral part
of cap 44 and may be made from the same material as the
outer surface of the cap or from some other suitable type
of metal, which is physically and thermally bonded to the
cap. The diameter of the ribs may be a few tenths of a
millimeter in the present example. The integral
construction of ribs 50 with cap 44 causes sensors 48 to
be in thermal communication with the outer surface of the
cap, i.e., the temperature inside ribs 50 closely tracks
the temperature of the outer surface. The ribs are thick
enough to thermally insulate these sensors from the
irrigation fluid in cavity 58. As a result, temperature
sensors 48 measure the true temperature of the outer
surface of cap 44, which most accurately reflects the
temperature of the tissue with which the cap is in
contact.
Typically, distal end 30 contains other functional
components, which are outside the scope of the present
disclosure and are therefore omitted for the sake of
simplicity. For example, the distal end of the catheter
may contain steering wires, as well as sensors of other
types, such as a position sensor and/or a contact force
sensor. A catheter containing sensors of these sorts is
described, for example, in U.S. Patent Application
12
Publication 2009/0138007.
Fig. 3 is a schematic sectional view of distal end
30, in accordance with another embodiment of the present
invention. Elements of this embodiment that are similar
to corresponding elements in the embodiment of Figs. 2A
and 2B are marked with the same indicator numbers. In
the embodiment of Fig. 3, a conductive, perforated cap
64, attached to the distal end of insertion tube 42, is
designed to have very low thermal capacity, and sensors
48 are held in contact with cap 64. As a result of this
configuration, the temperature of cap 64 more closely
track changes in the actual tissue temperature, and
sensors 48 more closely track the temperature of the
outer surface of cap 64. Sensors 48 thus provide a more
accurate, timely indication of changes in the temperature
of the tissue with which cap 64 is in contact.
As illustrated in Fig. 3, cap 64 contains an inner
wall 60, which is not perforated, in close proximity and
parallel to the cap. Lumen 54 supplies irrigation fluid
to a cavity 66 that is formed between cap 64 and wall 60,
and the irrigation fluid exits this cavity through
apertures 46 in cap 64.
Typically, cap 64 and wall
comprise thin shells of metallic material and are held
apart by small metallic spacers 62, around which the
fluid is able to flow within cavity 66. These
spacers
may be distributed within cap in any suitable
arrangement, for example in pairs (like the pair shown in
Fig. 3) of axially-spaced sensors at different
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circumferential locations. Spacers 62
also hold
temperature sensors 48 in thermal communication with the
outer surface of cap 64, while insulating the sensors
from the surrounding irrigation fluid in cavity 66. Even
without the insulating effect of spacers 62, the effect
of the irrigation fluid temperature on sensors 48 in this
embodiment is minimal due to the small volume of cavity
66 (relative to cavity 58 in the preceding embodiment,
for example).
In a configuration suitable for intracardiac
ablation, cap 64 has an outer diameter of about 2.5 mm
and a similar length. The thickness of both cap 64 and
wall 60 is about 100 pm, while apertures 46 have a
diameter in the range of 25-100 pm. Although cap 64 and
wall 60 are very thin, the mechanical integrity of the
entire structure is maintained by connecting the cap and
wall together with spacers 62.
Figs. 4A-4C schematically illustrate a catheter cap
70, in accordance with yet another embodiment of the
present invention. Cap 70 may be
used at distal end 30
of catheter 22 in place of the caps shown in the
preceding embodiments. Fig. 4A is a schematic, pictorial
illustration of cap 70, while Fig. 4B is a schematic end
view showing the interior of the cap, and Fig. 4C is a
sectional view taken along the line IVC-IVC in Fig. 4B.
Cap 70 comprises a side wall 74 that is relatively
thick, on the order of 0.4 mm thick, in order to provide
the desired thermal insulation between temperature
sensors 48 and the irrigation fluid inside a central
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cavity 76 of the tip. As in the preceding embodiments,
the irrigation fluid exits cavity 76 through apertures
46. Sensors 48 are mounted in hollow tubes 78, which are
filled with a suitable glue, such as epoxy and fitted
into longitudinal bores 72 in side wall 74. Tubes 78 may
comprise a suitable plastic material, such as polyimide,
and may be held in place by a suitable glue, such as
epoxy. This arrangement provides an array of six sensors
48 as in the preceding embodiments, with possible
advantages of greater ease of manufacture and durability.
Although a number of particular implementation
examples have been shown and described above, alternative
implementations of the principles embodied in these
examples will be apparent to those skilled in the art
after reading the foregoing description and are
considered to be within the scope of the present
invention. It will thus
be appreciated that the
embodiments described above are cited by way of example,
and that the present invention is not limited to what has
been particularly shown and described hereinabove.
Rather, the scope of the present invention includes both
combinations and subcombinations of the various features
described hereinabove, as well as variations and
modifications thereof which would occur to persons
skilled in the art upon reading the foregoing description
and which are not disclosed in the prior art.
